[
AAPRO, M., BOSSI, P., DASARI, A., FALLOWFIELD, L., GASCÓN, P., GELLER, M. A., JORDAN, K., KIM, J. W., MARTIN, K., PORZIG, S. Digital health for optimal supportive care in oncology: benefits, limits, and future perspectives. Supportive Care in Cancer. 2020. vol. 28, no. 10, p. 4589–4612. DOI: 10.1007/s00520-020-05539-1.
]Search in Google Scholar
[
APPLE. Apple Watch – Compare models. [online]. Available at: https://www.apple.com/watch/compare/?afid=p238%7CsnZgeoZeS-dc_mtid_1870765e38482_pcrid_601516710177_pgrid_99322576784_pntwk_g_pchan__pexid_30368077007_&cid=aos-us-kwgo---slid-gsi8KLF7--product-.
]Search in Google Scholar
[
APPLE. ECG app and irregular heart rhythm notification available today on Apple Watch. [online] Available at: https://www.apple.com/mg/newsroom/2019/03/ecg-app-and-irregular-rhythm-notification-on-apple-watch-available-today-across-europe-and-hong-kong/.
]Search in Google Scholar
[
APPLE. Using Apple Watch for Arrhythmia Detection. [online] Available at: https://www.apple.com/healthcare/docs/site/Apple_Watch_Arrhythmia_Detection.pdf.
]Search in Google Scholar
[
BROWN, D. Digital Therapeutics Regulation: 3 Leading Countries (inc. FDA, MDR, & DiGA). 2021. [online] Available at: https://www.smartpatient.eu/blog/fda-mdr-digital-therapeutics-regulation-leading-countries.
]Search in Google Scholar
[
BUNDESMINISTERIUM FÜR GESUNDHEIT. Ärzte sollen Apps verschreiben können [Driving the digital transformation of Germany’s healthcare system for the good of patients]. 2020. [online] Available at: https://www.bundesgesundheitsministerium.de/digitale-versorgung-gesetz.html.
]Search in Google Scholar
[
COSSIO, M. The power of wearable health Technology: The approval process for the Apple Watch as a Class II medical device. 2023. [online] Available at: https://www.linkedin.com/pulse/power-wearable-health-technology-approval-process-apple-manuel-cossio/.
]Search in Google Scholar
[
digital Therapeutics (DTX). European Data Protection Supervisor. [online] Available at: https://www.edps.europa.eu/press-publications/publications/techsonar/digital-therapeutics-dtx_en.
]Search in Google Scholar
[
EUROPEAN COMMISSION. Extension of the Mdr Transitional Period and Removal of the ‘Sell Off’ Periods. 2023, part I, point 1. [online] Available at: https://health.ec.europa.eu/system/files/2023-07/mdr_proposal_extension-q-n-a.pdf.
]Search in Google Scholar
[
EUROPEAN COMMISSION. Public Health: Medical Devices – EUDAMED. [online] Available at: https://health.ec.europa.eu/medical-devices-eudamed/overview_en.
]Search in Google Scholar
[
EUROPEAN COMMISSION. Questions and Answers on the progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation. 2021. [online] Available at: https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_5210.
]Search in Google Scholar
[
EUROPEAN COMMISSION. Single Market Compliance Space: Notified bodies (NANDO). [online] Available at: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies.
]Search in Google Scholar
[
FÜRSTENAU, D., GERSCH, M., SCHREITER, S. digital Therapeutics (DTX). Business & Information Systems Engineering. 2023, vol. 65, no. 3, pp. 349–360. DOI: https://doi.org/10.1007/s12599-023-00804-z.
]Search in Google Scholar
[
GOPAL, G. V., SUTER-CRAZZOLARA, C., TOLDO, L., EBERHARDT, W. digital transformation in healthcare – architectures of present and future information technologies. Clinical Chemistry and Laboratory Medicine. 2019, vol. 57, no. 3, pp. 328–335. DOI: 10.1515/cclm-2018-0658.
]Search in Google Scholar
[
GRAEME, L., HARMON, S., DOVE, E. Mason and McCall Smith’s Law and Medical Ethics. Oxford University Press, 2019.
]Search in Google Scholar
[
GREER, S. L., ROZENBLUM, S. (eds.). Chapter 5: The EU market shaping health. In: GREER; ROZENBLUM (eds.). Everything you always wanted to know about European Union health policies but were afraid to ask. Third, revised edition. World Health Organization. Regional Office for Europe, 2022, pp. 183–219. [online] Available at: <https://www.ncbi.nlm.nih.gov/books/NBK590173/>
]Search in Google Scholar
[
GRIEB, J., TSCHAMMLER, D., FÄRBER, C., WOITZ, S. Digital Health Laws and Regulations Germany 2023–2024. International Comparative Legal Guides International Business Reports, 2023. [online] Available at: <https://iclg.com/practice-areas/digital-health-laws-and-regulations/germany>
]Search in Google Scholar
[
GROENE, N., SCHnECK, L. Covering digital health applications in the public insurance system: how to foster innovation in patient care while mitigating financial risks—evidence from Germany. Frontiers in Digital Health. 2023, vol. 5, 1217479 DOI: 10.3389/fdgth.2023.1217479.
]Search in Google Scholar
[
HERVEY, T. K., McHALE, J. V. European Union Health Law: Themes and Implications. Cambridge: Cambridge University Press, 2015.
]Search in Google Scholar
[
HÖLLE, K. Current developments on the MDR transition periods. TaylorWessing. 2023. [online] Available at: <https://www.taylorwessing.com/en/insights-and-events/insights/2023/03/aktuelle-entwicklungen-zu-den-ubergangsfristen-der-mdr>
]Search in Google Scholar
[
KAR, S. N. Apple obtains FDA 510(K) clearance for a new AFib history feature for Apple Watch. 2022. [online] Available at: <https://www.myhealthyapple.com/apple-obtains-fda-510k-approval-for-a-new-afib-history-feature-prior-to-wwdc/>
]Search in Google Scholar
[
KEUTZER, L., SIMONSSON, U.S.H. Medical device apps: an introduction to regulatory affairs for developers. JMIR mHealth and Health. 2020, vol. 8, no. 6, e17567, pp. 1–2. DOI: 10.2196/17567.
]Search in Google Scholar
[
MOSSIALOS, E. (ed.). Health systems governance in Europe: the role of European Union law and policy. Cambridge University Press, 2010.
]Search in Google Scholar
[
NÕMPER, A., SOOTAK, J. Meditsiiniõigus [Medical Law]. Tallinn: Juura, Õigusteabe AS, 2007.
]Search in Google Scholar
[
RASSI-CRUZ, M., VALENTE, F., CANIZA, M. V. digital therapeutics and the need for regulation: how to develop products that are innovative, patient-centric and safe. Diabetology & Metabolic Syndrome. 2022, vol. 14, no. 1. pp. 1–7. DOI: 10.1186/s13098-022-00818-9.
]Search in Google Scholar
[
ROWLAND, D., KOHL, U., CHARLESWORTH, A. Information technology law. London: Routledge, 2017.
]Search in Google Scholar
[
SCHEID, J. L., REED, J. L., WEST, S. Commentary: Is wearable fitness technology a medically approved device? Yes and no. International Journal of Environmental Research and Public Health. 2023, vol. 20, no. 13, p. 6230. DOI: 10.3390/ijerph20136230.
]Search in Google Scholar
[
TERVISEPORTAAL. Sinu värav terviseteenustesse [Your gateway to health services]. [online] Available at: <https://www.digilugu.ee/login>
]Search in Google Scholar